Senior Expert, Method Validation

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage cell therapy company focused on the development of autologous and off-the-shelf, allogeneic therapies to treat cancer. Tessa’s Virus-Specific T cell (VST) technology platform harnesses the body’s potent anti-viral immune response and has shown early efficacy and a strong safety profile against solid tumors in clinical trials.

Tessa is building a portfolio of innovative, next-generation therapies through combination approaches and other novel immuno-oncology technologies. This portfolio includes a rapidly growing clinical pipeline that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, head and neck cancer, and lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our global team of over 200 employees is passionate about bringing life-saving cancer treatments to patients all over the world. If this excites you too, explore our job opportunities and see if there’s a match.

For more information on Tessa, please visit www.tessatherapeutics.com.

Job Position
Senior Expert, Method Validation

Reports To
Associate Director, Quality Control

Responsibilities

  • Responsible for drafting protocols and reports for in-house assays method validation & qualification in accordance with cGMP requirements and applicable regulatory guidelines
  • Works closely with QC analysts to plan, organize and execute the validation & qualification activities as per approved protocols and ensures resources are used efficiently and effectively for timely delivery of results meeting project timelines
  • Supports the implementation of validated in-house assays and the establishment of associated workflow, standard operating procedures
  • Establishes trend analysis of test results on the finished products, stability of drug substances & products supporting product quality review exercise
  • Establishes program(s) and procedures to monitor the performance and manage the life cycle of in-house assays ensuring they are in a state-of-control
  • Provides necessary technical expertise to support investigations of non-compliances, deviations and out-of-specifications
  • Participates in technical transfer, assay development & qualification projects and response to regulatory queries pertaining to QC testing
  • Attends and / or organizes inter-departmental or cross-departmental working group meetings and discussions relating to technical aspects of QC tests
  • Be involved in technical training for junior team members

Requirements

  • Bachelor’s or Master’s degree holder in Biology/Life Science/Biochemistry/Biotechnology/Bioengineering or equivalent with at least 5 years of working experience in technical position in biopharmaceutical industry and cGMP environment
  • In-depth knowledge and understanding in Cell & Molecular Biology and USFDA & ICH guidelines for method validation are required
  • Hands-on experience in the following areas are preferred:
    • Quality Management System and Current Good Manufacturing Practice
    • US Pharmacopeia test methods for Cell, Gene & Tissue based products
    • QPCR and cell-based assays method validation
    • Statistical process control (SPC) and statistical analysis
    • Risk assessment (for example, FMEA)
    • TrackWise and LIMS computer systems
  • Being in the leadership role for at least 2 years is advantageous
  • A good team player with excellent planning, coordination and inter-person skills
  • Being open-minded, resourceful and able to think strategically when dealing with challenges and solving problems
  • Attention to details and able to undertake tasks timely and proactively
  • Proficient in technical writing and presentation
  • Able to work in a fast-paced environment and manage multiple projects
  • Able to work with people from different background and levels